Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

A Single-Center, Prospective Study in Healthy Volunteers for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.

Study Overview

• Status: Completed
• Conditions: Oxygen Deficiency
• Intervention / Treatment: Device: Masimo O3 Regional Oximeter

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 45 years, inclusive
• Willing and able to provide written informed consent
• Healthy subjects

Exclusion Criteria:

• Pregnant women
• Presence of any cardiovascular or pulmonary disease
• Exposure to high altitude(s) (>2000 m) within 30 days prior to the study
• Known allergy to intravenous contrast medium or heparin
• Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study
• Patients deemed not suitable for the study at the discretion of the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Healthy Adult Volunteers; Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived tissue oxygen saturation (rSO2) readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.	Device: Masimo O3 Regional Oximeter; Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2	Accuracy of the sensors will be determined by comparing somatic regional oxygen saturation (rSO2) readings from the O3 sensor and blood reference oxygen saturation values and calculating the Arithmetic root mean square (ARMS).	1 visit up to 8 hours

Collaborators and Investigators

• Sponsor: Masimo Corporation
• Collaborators: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2020
• Primary Completion (ACTUAL): June 2, 2021
• Study Completion (ACTUAL): June 2, 2021

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: SCHE0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes